Prostate CancerPROSTRACKNCT02279693
Evaluation of the Dose Received by the Prostate With in Vivo Dosimetry in Patients Treated With Daily IGRT Associated With IMRT Using Two Repositioning Techniques for Localized Prostate Cancer
A study testing CBCT, fiducial marker (kV imaging) and IGRT Associated With IMRT in people with Prostate Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
This study evaluates the dose received by the prostate with in vivo dosimetry when delivering image guided radiation therapy (IGRT) associated with intensity modulated radiation therapy (IMRT) for patients with localized prostate cancer using two repositioning techniques: fiduciary markers or soft tissues. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- CBCT, fiducial marker (kV imaging) and IGRT Associated With IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2014to 6 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male > 18 years
- carcinoma of the prostate histologically confirmed
- OMS 0-1
- localized stage
- favorable, intermediate and unfavorable groups according to NCCN or D'Amico classification
- patients must have signed a written informed consent form
- patients must be affiliated to a Social Health Insurance.
Who cannot join
- metastasis
- indication for pelvic radiation
- anticoagulant therapy
- lateral or bilateral hip replacement
- patient receiving an adult protective services
- Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the dose received by the prostate with in vivo dosimetry when delivering image guided radiation therapy (IGRT) associated with intensity modulated radiation therapy (IMRT) for patients with localized prostate cancer using two repositioning techniques: fiduciary markers or soft tissues.
Read the detailed description
10 participants will receive a cone beam computed tomography (CBCT) repositioning, while the other 10 will receive a kV imaging of fiducial marker repositioning. The principal objective is to evaluate and compare the dose received by the prostate using two repositioning techniques.
- Conditions
- Prostate Cancer
- Being tested
- CBCT, fiducial marker (kV imaging), IGRT Associated With IMRT
- Keywords
- Raypilot dosimetry, CBCT (cone beam computed tomography)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCTOther
10 participants will receive a cone beam computed tomography (CBCT) repositioning
fiducial marker (kV imaging)Other
10 participants will receive a kV imaging of fiducial marker repositioning.
IGRT Associated With IMRTRadiation
| Study group | Role | What they receive |
|---|---|---|
| CBCT | Other | cone beam computed tomography (CBCT) repositioning Receives: Other: CBCT; Radiation: IGRT Associated With IMRT |
| fiducial markers | Other | kV imaging of fiducial marker repositioning Receives: Other: fiducial marker (kV imaging); Radiation: IGRT Associated With IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
dosimetry (measurement of the absorbed dose, delivered to prostate, by ionizing radiation)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study start22 Dec 2014
- Primary completion22 Dec 2014
- Study completion6 Aug 2019
Why it stopped: feasibility problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles CREHANGE, MD, PhD, Principal investigator, Centre Georges François Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279693
- Sponsor's protocol ID
- 2014-A00122-45
- Acronym
- PROSTRACK
- Status last verified
- Feb 2024
- First submitted
- 28 Oct 2014
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dose Received by the Prostate With in Vivo Dosimetry in Patients Treated With Daily IGRT Associated With IMRT Using Two Repositioning Techniques for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02279693
- Acronym / sponsor ID
- PROSTRACK / 2014-A00122-45
- Conditions
- Prostate Cancer
- Keywords
- Raypilot dosimetry, CBCT (cone beam computed tomography)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: feasibility problem
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 22 Dec 2014 (actual)
- Primary completion
- 22 Dec 2014 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the dose received by the prostate with in vivo dosimetry when delivering image guided radiation therapy (IGRT) associated with intensity modulated radiation therapy (IMRT) for patients with localized prostate cancer using two repositioning techniques: fiduciary markers or soft tissues.
Detailed description
10 participants will receive a cone beam computed tomography (CBCT) repositioning, while the other 10 will receive a kV imaging of fiducial marker repositioning. The principal objective is to evaluate and compare the dose received by the prostate using two repositioning techniques.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBCT | Other | Other: CBCT, Radiation: IGRT Associated With IMRTcone beam computed tomography (CBCT) repositioning |
| fiducial markers | Other | Other: fiducial marker (kV imaging), Radiation: IGRT Associated With IMRTkV imaging of fiducial marker repositioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- male > 18 years
- carcinoma of the prostate histologically confirmed
- OMS 0-1
- localized stage
- favorable, intermediate and unfavorable groups according to NCCN or D'Amico classification
Key exclusion criteria (6 listed)
- metastasis
- indication for pelvic radiation
- anticoagulant therapy
- lateral or bilateral hip replacement
- patient receiving an adult protective services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBCT10 participants will receive a cone beam computed tomography (CBCT) repositioning | Other | CBCT |
| fiducial marker (kV imaging)10 participants will receive a kV imaging of fiducial marker repositioning. | Other | fiducial markers |
| IGRT Associated With IMRT | Radiation | CBCT, fiducial markers |
Primary outcome
dosimetry (measurement of the absorbed dose, delivered to prostate, by ionizing radiation)
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: feasibility problem). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles CREHANGE, MD, PhD principal investigator
Centre Georges François Leclerc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBCT, fiducial marker (kV imaging) and IGRT Associated With IMRT in people with Prostate Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: feasibility problem). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dosimetry (measurement of the absorbed dose, delivered to prostate, by ionizing radiation) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.